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FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

pharmaphorum

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. This market information is based on IQVIA data for the 12 months ended September 30, 2020.

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Civica plans shake-up of insulin sector with low-cost biosimilars

pharmaphorum

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

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Insulin price caps on the horizon as Senate leader plans vote

pharmaphorum

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Assuming the bill is later passed by the Senate and signed into law by President Biden, the insulin cap would take effect beginning in 2023.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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